Ablation catheter and ablation apparatus

ABSTRACT

The present invention relates to an ablation catheter (1) for the ablation of tissues comprising: a telescopic tubular body (4) in turn comprising an external tubular body (4a) and an internal tubular body (4b) concentric with each other, and a rod-like guiding element (5) at least partly housed in the internal tubular body (4b) with at least one free end (5a) protruding from the internal tubular body (4b) in correspondence with a distal end of the telescopic body (4); a positioning head (2, 2″, 2′″, 2°, 2*, 2{circumflex over ( )}) and an ablation head (3) in correspondence with the distal end of the telescopic body (4), the positioning head (2,2″,2″′,2′,2*,2{circumflex over ( )}) being situated in the proximity of the free end (5a) of the rod-like guide, and the ablation head (3) in the proximity of the positioning head (2, 2″, 2″′, 2°, 2*, 2{circumflex over ( )}), in a remote position with respect to the free end (5a); a control handpiece at a proximal end of the telescopic body (4) coupled with the guiding element (5), the ablation head (3), the positioning head (2, 2″, 2′″, 2°, 2*, 2{circumflex over ( )}) and the telescopic tubular body (4); wherein the ablation head (3) comprises at least two ablation elements or petals (3a) that can be moved from a rest position in which they are housed in the external tubular body (4a) and an operating position in which they protrude from the external tubular body (4a) like a petal; wherein each of the ablation elements or petals (3a) comprises: a continuous ablation electrode (3b) which extends without interruption over a circumferential peripheral portion of each petal (3a), substantially along an arc of circumference having a longitudinal axis of the rod-like guiding element (5) as its centre; two side portions (3c) of the petal (3a), each connected to an end of the ablation electrode (3b), in correspondence with a curved section, the side portions (3c) and the ablation electrode (3b) being integral with each other, formed by means of the same folded metallic conductor, each ablation petal (3a) being separate and distinct from another ablation petal (3a) of the ablation head, all the ablation petals (3a) of the ablation head being separately connected to a distinct electric energy generator to cause a radiofrequency ablation and/or a pulsed filed ablation in a powered ablation electrode condition (3b).

This application is a continuation of U.S. patent application Ser. No.15/127,464 filed Sep. 20, 2016 (pending), which is a 371 of PCTApplication PCT/IB2015/051998 filed Mar. 18, 2015 and claims priority ofIT Application MI2014A000467 filed Mar. 20, 2014, the entire contents ofeach of which are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to the general field of catheters andablation apparatuses for human tissue ablation or, more generally, foranimals.

STATE OF THE ART

Various type of ablation catheters are known in the state of the art.

In general, the term “ablation” refers, in the medical field, to thetreatment of a tissue suitable for removing a surface part of the sametissue or necrotizing it and/or causing a cicatrisation of the same.

The ablation referred to in this invention is specifically destined forinterrupting the electric continuity of the tissue in correspondencewith the zone treated by ablation.

In this sense, ablation can take place with a series of treatments, forexample by means of an electric current, by heat, cryogenics,radiofrequencies or other forms of treatment.

A first example of a radiofrequency ablation catheter is that capable ofeffecting focal ablations: in fact, it has an actual ablation tip incorrespondence with its free end.

In the treatment, the catheter is inserted by means of percutaneousaccess and is brought to the area to be ablated.

The surgeon then activates the ablation tip and effects the ablation ofthe tissues by means of a continuous approach/distancing movement of theablation tip from the tissue, necessary for not maintaining anexcessively lengthy contact of the tip with the tissue, with consequentdamage that can be critical.

The ablated area is therefore defined by the combination of ablatedpunctiform zones.

This operation is particularly delicate as an excessively prolongedcontact of the tip with the tissue can lead to serious injury to thelatter.

Let us consider, for example, the ablation of the antrum of thepulmonary veins in the case of atrial fibrillation: the antrum of theveins to be ablated is situated in correspondence with the conjunctionof the veins with the heart; an excessively prolonged contact of theablation tip with the tissue could lead to a piercing of the wall of theheart and, if not immediately treated surgically, could have fatalconsequences for the patient.

The ablation manoeuvring itself, on the other hand, must also besufficiently prolonged for ensuring that the ablation is effective anddoes not have to be repeated.

This situation, already complex, is made even more so due to the factthat this type of ablation generates substantially punctiform ablatedareas, and consequently the treatment must be repeated numerous times,in order to join these punctiform areas until they form a substantiallycontinuous ablation line to interrupt the electric continuity of thetissue and isolate the atrium from the venous electric disturbances. Theintervention therefore has relatively lengthy times which require aprolonged sedation of the patient.

Furthermore, in order to improve the precision of the treatment, theradiofrequency ablation catheter described above requires a second,separate, catheter, i.e. a mapping catheter, which obtains informationon the position and effectiveness of the treatment of the single areasto be treated.

This implies having to introduce and manoeuvre two separate catheters,with relatively high encumbrance, costs and overall proceduraldifficulties.

Another type of known catheter, specifically suitable for the ablationof the antrum of the pulmonary veins (for the treatment of atrialfibrillation) is described in international patent applicationPCT/EP2012/056626.

This catheter was created for at least partly solving the problemsindicated above.

It comprises a positioning head and an ablation head and a telescopictubular body provided with an external tubular body, an internal tubularbody, concentric with each other, and a rod-like guiding element atleast partly housed in the internal tubular body with a free endprotruding from the internal tubular body.

The positioning head is situated in the proximity of the free end of therod-like guiding element, whereas the ablation head is positioned closeto the positioning head, in a position far from the free end, i.e. onthe opposite side of the latter with respect to the positioning head.

In short, the positioning head and the ablation head can be inflated bysuitable fluids so as to pass from a rest position in which they aredeflated and not expanded, to an operating condition in which they areinflated and expanded.

Although this catheter represents a considerable step forward withrespect to those having an “ablation tip” described above, it still hasvarious drawbacks.

A first drawback is linked to the fact that it has a certain encumbranceeven when in a rest condition: it should in fact be remembered thatcatheters are inserted in the patient's veins and are brought throughthese to the treatment zones, which can often be distant from the inletpoint (for example in the treatment of atrial fibrillation, the catheteris inserted in the femoral vein and brought up to the heart).

In this sense, it is evident that it is extremely important to limit theencumbrance of the catheter in order to facilitate its passage in theveins of the patient undergoing treatment.

Another drawback is linked to the fact that the ablation head of thecatheter described therein is a torus, which, once expanded, haswell-defined dimensions: in a functioning condition, its dimensionscannot therefore be varied.

This implies knowing the exact dimensions of the area to be treated, inorder to be able to select the correct catheter, i.e. having a toruswhich, in expanded conditions, has dimensions coherent with those of thearea to be treated.

A further drawback, again linked to the dimensions of the torusdescribed above, lies in the fact that the same catheter cannot be usedfor different applications, for example, applications in which thedimensions required by the ablation head differ significantly (forexample for veins having a different ostium in the same patient).

Yet another drawback relates to the fact that some ablated areassometimes require a second ablation treatment in order to be effective.

An example is the case of the ablation of the antrum of a vein: theablation line in which the tissue is altered by the treatment issubstantially a circumference; if an arc of the same is not treatedsufficiently, the surgeon must proceed with a new treatment.

The intrinsic characteristics of the catheter described above, however,imply that a new treatment presumably also involves areas of thecircumference that have already been sufficiently treated, thereforeexposing the tissue to potential injury.

Another known ablation catheter is that described in US2013/0103027. Inthis case, there are two separate heads in the distal portion, anablation head and a positioning head.

The ablation head has angled thread-like supports on which discreteablation electrodes (punctiforms) are assembled.

Yet another ablation catheter is that described in US2005171536: also inthis case, the ablation head has electrodes assembled on a supportingstructure.

The same can be said, in short, for the catheter described in U.S. Pat.No. 6,893,438.

Although these types of embodiments are capable of overcoming some ofthe drawbacks described above with respect to the more traditionalcatheters (with a tip and inflatable), they are, however, relativelycomplex to construct, they require specific conductors for feeding theelectrodes and occupy considerable space.

Furthermore, it should be pointed out that during the ablation operationin catheters with discrete electrodes, the risk of the formation ofblood clots is relatively high, due to the fact that, on the whole, itis difficult to make the electrodes of each wire of the supportingstructure adhere perfectly to the surface of tissue to be ablated.

Another problem encountered with the “multi-electrode” cathetersdescribed above is due to the discrete arrangement of the electrodes:said electrodes, which can be activated with a monopolar or bipolarradiofrequency supply, ablate the tissue surrounding the pulmonaryveins, leaving however gaps between one ablation point and another. Inorder to fill these gaps, repeated applications of the same catheter oreven the introduction of a focal catheter and a mapping catheter arevery frequently required for identifying and completing the ablation inareas not completely treated, with a consequent increase in theprocedural risk for the patient and an increase in the times andintervention costs.

On the whole, radiofrequency ablation is more difficult to control, dueto eddy currents that can be generated in the conductors along thecatheter, from the generator (external) to the ablation head, which canmake it difficult to accurately control the quantity of energy supplied.

OBJECTIVES OF THE INVENTION

A first objective of the present invention is to overcome the drawbacksof the known art.

A second objective of the invention is to provide a catheter for theablation of tissues which has the minimum possible dimensions and at thesame time has an ablation profile which is as ample and uniform aspossible.

A further objective is to also enable ablations to be effected of onlypart of the tissue surrounding the ablation head, without requiring thatother parts already treated correctly be subjected to new treatment.

Yet another objective of the invention is to provide a catheter for theablation of tissues which is capable of shortening the time of theprocedure, thus reducing the time in which the patient is sedated.

An additional objective is to provide an ablation catheter which issafer to use, also in the case of moving tissue walls, and which avoidsinjury to or piercing of the walls.

A further objective of the invention is to provide an ablation catheterwhich, when in use, has a reduced formation of clots.

Yet another objective of the invention is to provide an ablationcatheter which, when in use, has a relatively simple regulation of theenergy supplied.

Another objective of the invention is to provide an ablation catheterwhich is capable of providing the surgeon with information relating tothe state of treatment of the tissue.

A first object of the invention therefore relates to an ablationcatheter and a second object of the invention relates to an ablationapparatus comprising said catheter according to the enclosed independentclaims.

The idea at the basis of the invention is to produce a catheter for theablation of tissues comprising:

-   -   a telescopic tubular body in turn comprising an external tubular        body and an internal tubular body, concentric with each other,        and a rod-like guiding element at least partly housed in the        internal tubular body with at least one free end protruding from        the internal tubular body in correspondence with a distal end of        the telescopic body;    -   a positioning head and an ablation head in correspondence with        the distal end of the telescopic body, the positioning head        being situated in the proximity of the free end of the rod-like        guide, and the ablation head in the proximity of the positioning        head, in a remote position with respect to the free end;    -   a control handpiece at a proximal end of the telescopic body        coupled with the guiding element, the ablation head, the        positioning head and the telescopic tubular body; the ablation        head comprises at least two ablation elements or petals that can        be moved from a rest position in which they are housed in the        external tubular body and an operating position in which they        protrude from the external tubular body like a petal;    -   characteristically, according to the invention, each of the        ablation elements or petals comprises:    -   a continuous ablation electrode which extends without        interruption over a circumferential peripheral portion of each        petal, substantially along an arc of circumference having a        longitudinal axis of the rod-like guiding element as its centre    -   two side portions of the petal, each connected to an end of the        ablation electrode, in correspondence with a curved section    -   the side portions and the ablation electrode being integral with        each other, formed by means of the same folded metallic        conductor    -   each ablation petal being separate and distinct from another        ablation petal of the ablation head,    -   all the ablation petals of the ablation head being separately        connected to a distinct electric energy generator to cause a        radiofrequency ablation and/or a pulsed filed ablation (PFA) in        a powered ablation electrode condition.

In this way, the drawbacks indicated above are brilliantly overcome.

The ablation petals can in fact remain in rest position during theinsertion and positioning of the catheter, until it has reached theposition in which the treatment is to be effected: in this position,they are contained inside the external tubular element of the catheterand do not have any encumbrances or protrusions which could complicatethe positioning manoeuvre and passage in the veins.

The reduced dimensions of the catheter, obtained through theadvantageous expedients of the invention, therefore allow the catheterto be easily inserted and positioned.

In this respect, it should be pointed out that the fact that the sideportions and the ablation electrode are integral with each other, formedby the same folded metallic conductor, allows a considerable reductionin the encumbrance and, at the same time, an optimum positioning whichallows possible clots to be reduced: the intrinsic elasticity of thewire (or thin lamina) of which it is formed—and all the same for thewhole petal—allows it to be positioned in optimum contact with thetissue to be subjected to ablation treatment, with the result that it istreated uniformly.

The Applicant has discovered that these advantages can be obtained whenthe petals are of a shape-memory metallic conductor, preferably CuZnAl,or CuAlNi, or NiTi alloys, still more preferably petals are of Nitinol,produced with a single wire having a circular section with a diameter Dand with the following ratio between the diameter D and the length L ofthe active part (circumferential part of the petal, i.e. electrode)

D/L ranging from 0.015 to 0.025, preferably equal to about 0.02.

This particular ratio linked to the material with which the petal isproduced (shape-memory metallic conductor, preferably Nitinol) ensuresthat optimal electric characteristics are obtained together with anoptimum adhesion of the petal on the surface to be treated, so that itis possible to obtain perfectly straight lesions, without necrotizedareas.

With a length L ranging from 10 to 25 mm, the relative optimum diameterpreferably ranges from 0.20 mm to 0.50 mm, preferably 0.30 mm.

At the same time, the presence of continuous, non-discretized ablationelectrodes, allows ablation sections having a much larger extension thanthose relating to catheters with an ablation tip, to be produced, thusreducing the treatment time during which the patient must be sedated.

Furthermore, with respect to structures in which the electrode isdiscrete and applied to a supporting structure, it can be noted that inthis case, it is the same structure, conductor, that acts as electrode:the latter is therefore uniformly “distributed” so as to extend over thewhole circumferential portion of the petal without interruptions.

According to a particularly advantageous characteristic, the ablationelements, or at least the relative segments, can be selectivelyactivated, as each is connected to its own specific generator, part ofthe ablation apparatus which also comprises the same catheter of theinvention: in this way, the surgeon can advantageously choose which andhow many of these to activate for repeating the treatment, which cantherefore correspond solely to the areas that have not been sufficientlytreated, avoiding re-treating areas of tissue that have already beentreated correctly or areas at risk for the patient.

In order to allow an optimum control of the energy supplied, accordingto an independent aspect of the invention, additional conductors areenvisaged, which are useful for eliminating eddy currents that may begenerated.

This feature can be advantageously combined with those of the catheterdescribed herein, thus providing an extremely precise ablation catheterin the treatment.

In particular, but not exclusively, the ablation catheter of theinvention is advantageously suitable for the ablation of the antrum ofpulmonary veins for limiting or eliminating the atrial fibrillationphenomenon, thanks to the interruption in the electric currents inducedby the veins themselves.

Details on this type of treatment for atrial fibrillation, itseffectiveness and approach, can be found in scientific literature andconsequently no further mention will be made thereof in the presentdescription.

Other unlimited uses of the catheter of the invention can, for example,be for the ablation of renal arteries, as a cure for high bloodpressure.

Also in this case, no medical details are provided on the treatment asthese can be found in scientific literature.

Other optional advantageous features of the invention are contained inthe enclosed claims, which should be considered as being an integralpart of the present description.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is described hereunder with reference to non-limitingexamples, provided for illustrative and non-limiting purposes in theenclosed drawings. These drawings illustrate different aspects andembodiments of the present invention and, when appropriate, referencenumbers illustrating structures, components, materials and/or similarelements in different figures are indicated with similar referencenumbers.

FIG. 1 illustrates a side view of the distal end of the catheter of theinvention in a positioning condition;

FIG. 2 illustrates a side view of the end of the catheter of FIG. 1 in afunctioning condition;

FIG. 3 illustrates a front view of the catheter of the invention in aninsertion condition;

FIG. 4 illustrates a front view of the catheter of the invention in apositioning condition corresponding to that of FIG. 1;

FIG. 5 illustrates a front view of the catheter of the invention in afunctioning condition corresponding to that of FIG. 2;

FIGS. 6-10 illustrate side views of variants of a detail of the catheterof the invention;

FIGS. 11 and 12 illustrate a preferred embodiment of the catheter of theinvention, in a side and perspective view;

FIGS. 13 and 14 illustrate the ablation petals of the catheter of FIGS.11, 12, in a side and perspective view;

FIGS. 15 and 16 illustrate the positioning head of the catheter of FIGS.11, 12, in a side and perspective view;

FIG. 17 illustrates a section along the plane AA of FIG. 11;

FIGS. 18 and 19 illustrate sections along the planes AA and BB of FIG.13;

FIGS. 20 and 21 illustrate sections along the planes AA, BB and CC ofFIG. 15.

DETAILED DESCRIPTION OF THE INVENTION

Whereas the invention can undergo various modifications and alternativeconstructions, some relative illustrative embodiments are shown in thedrawings and are described hereunder in detail.

It should be understood, however, that there is no intention of limitingthe invention to the specific embodiment illustrated but, on thecontrary, the invention intends to cover all the modifications,alternative constructions, and equivalents that fall within the scope ofthe invention as defined in the claims.

The use of “for example”, “etc.”, “or” indicates non-exclusivealternatives, without limitation, unless otherwise specified. The use of“comprises” means “comprises, but not limited to” unless otherwisespecified.

With reference to the enclosed figures, these show an illustrative butnon-limiting embodiment of the catheter of the invention, indicated as awhole with reference 1.

The catheter 1 comprises a positioning head 2 and an ablation head 3,which will be described in further detail hereunder.

The catheter 1 also comprises a handpiece in a proximal position, i.e.the control portion that is located outside and can be used for theoperator for controlling the action of the catheter itself.

The control handpiece is positioned at a proximal end of the telescopicbody 4 and is operatively connected to the guiding element 5, theablation head 3, the positioning head 2,2″,2′″,2°,2*,2{circumflex over( )} and the telescopic tubular body 4 said “operative connection” canbe actuated in numerous ways, all known to skilled persons in the field,for example by means of control levers directly or indirectly connectedto the above-mentioned parts; consequently no further mention will bemade in this respect.

The form of the handpiece is of no particular interest for the presentinvention, as it is produced analogously to those known in the art;consequently no further detail is provided herein with respect to thehandpiece.

The catheter 1 comprises a telescopic tubular body 4 in turn comprising:an outer tubular body 4 a, an inner tubular body 4 b, concentric withrespect to each other.

A sheath 4 c, also eccentric with respect to the tubular bodies 4 a, 4b, is also envisaged for covering the outer tubular body.

The tubular bodies 4 a and 4 b are preferably cylindrical, even if, ingeneral, they can be oval or polygonal (with rounded corners).

The catheter 1 also comprises a rod-like guiding element 5 partly housedin the inner tubular body 4 b with a free end 5 a which protrudes fromthe inner tubular body 4 b.

The rod-like guiding element 5 is used by the surgeon for guiding themovement of the catheter 1 when inserting it into the patient's veins;this guiding element is per se of the known type and no further mentionwill be made thereof.

As can be seen in the figures, the positioning head 2 is situated in theproximity of the free end 5 a of the rod-like guide 5, whereas theablation head 3 is situated in the proximity of the positioning head 2,but in a remote position with respect to the free end 5 a; in otherwords, the ablation head 3, when in use, is positioned between the outertubular body 4 a and the positioning head 2 (see FIG. 2 or 11, 12, forexample).

In general, the ablation head 3 comprises a plurality of ablationelements or petals 3 a.

In the embodiment illustrated, there are four ablation petals 3 a, butthere could also be two, three or more.

A specific feature of the ablation elements 3 a is that they can bemoved, or rather extracted, from a rest position in which they arehoused in the outer tubular body 4 a (as in FIGS. 1, 3 and 4) to anoperating position in which they protrude from the outer tubular body 4a extending and broadening out both radially and axially towards thepositioning head (as in FIGS. 2, 5, 11-14).

The movement between the two positions, rest and operating, is effectedthanks to a mechanical control positioned in the handpiece of the deviceand which allows the controlled and adjustable extraction of theablation petals 3 a.

In short, between the inner tubular body 4 b and the outer tubular body4 a, there is at least one housing chamber 6, in which the petals 3 aare positioned in a rest condition and from which they are extracted tobe brought into an operating condition.

In some embodiments, a single housing chamber is envisaged for eachpetal 3 a, whereas in other embodiments, such as that illustrated, thereis only one chamber 6, which in a sectional and front view, issubstantially in the form of a circular crown, as it is formed betweenthe outer 4 a and inner 4 b tubular bodies.

This allows the elements 3 a, when in a rest condition, to be keptwithdrawn inside the chamber 6 during the positioning phase of thecatheter (see FIGS. 1, 3 and 4), without creating an obstacle during thepassage of the catheter inside the patient's veins, and to be extractedfrom the chamber 6 only when the catheter 1 is positioned.

At least one, preferably all, of the ablation elements 3 a comprise acontinuous (clearly visible in FIG. 5)—or distributed—ablation electrode3 b which extends without interruption over a circumferential portion,preferably peripheral, of each petal 3 a, substantially along an arc ofcircumference having a longitudinal axis of the rod-like guiding element5, as centre.

In other words, the electrode 3 b occupies the whole of the externalbody of the petal 3 a, as far as the folded portions with a largercurvature radius which connect it with two side portions 3 c of thepetal 3 a, each connected to an end of the ablation electrode (3 b).

Characteristically, the side portions 3 c and the ablation electrode 3 bare integral with each other, produced with the same folded metallicconductor, to which further reference will be made hereunder.

In short, the petal is composed of a single, folded, solid electricconductor (wire or lamina), of which the circumferential part 3 b formsthe actual electrode and the side parts 3 c form side portions of thepetal which preferably do not contribute to the ablation process, evenif traversed by an electric current.

This effect is obtained, for example, by coating the side portions 3 cwith a layer of electrically insulating material, preferably a paint(not illustrated in the figures).

Each ablation petal 3 a is separate and distinct from another ablationpetal of the ablation head and all the ablation petals 3 a of the headare connected separately to a separate electric energy generator tocause a radiofrequency ablation and/or a pulsed field ablation under apowered condition of the ablation electrode 3 b.

In this way, the quantity of energy to be supplied in relation to thedesired result, can be regulated with extreme precision.

The electrically conductive material forming the ablation petal 3 a ispreferably composed of a shape-memory metallic conductor, even morepreferably a Nitinol wire, a material which is known per se forbiomedical use; it should be noted that, in general, other metals/metalalloys suitable for the purpose, can also be selected.

As it is fundamental for the safety and success of the procedure toobtain a clear, continuous, ablation line, without causing surfacenecrosis and damage to the tissue, ideal conditions for enabling thiscan be obtained when the petals are of Nitinol, each produced with asingle wire having a circular section with a diameter D and with thefollowing ratio between the diameter D and the length L of the activepart (circumferential part of the petal, or electrode)

D/L ranging from 0.015 to 0.025, preferably equal to about 0.02.

The electrical and mechanical characteristics are therefore optimized inrelation to the advantages discussed above.

It should also be noted that by joining (ideally) the ablationelectrodes 3 b, they substantially develop along the same circumference,having the axis of the guiding element 5 as centre; only small arcs ofthis ideal circumference can remain unjoined (and therefore inactive inthe ablation treatment); in this way, during a treatment, an importantportion of a blood vessel can be ablated, leaving only small areas oftissue that do not receive direct treatment.

This can be obtained even more so thanks to the fact that, as the petals3 a are all produced with the same conductor and with the samedimensions, the elasticity is such that an optimal adherence of thepetal to the surface has been observed (the petal under the action ofthe force against the tissue, becomes elastically deformed until itadheres perfected to the tissue itself, regardless of rhythmic movementsof the same) obtaining optimum results in terms of ablation and also inpreventing the formation of clots.

In this sense, thanks to the optimal adherence, a reduced overallquantity of energy can in fact be supplied with respect to cases of theknown art, with a consequent lesser heating of the blood possibly incontact with the electrode; at the same time, there is also a lesserheating of the tissue, avoiding necrosis phenomena.

These small non-treated areas can be subsequently ablated by thesurgeon, if necessary, for example by rotating the whole catheter 1 onitself or, more advantageously, only the petals 3 a, keeping thepositioning head 2 fixed.

It should be pointed out that the small angular extension of the arcs inwhich the ablation electrode 3 b is not active, ensures that the surfacetreated by each activation of the ablation petals 3 a, is high, muchhigher than the known radiofrequency catheters with an ablation tipdescribed above.

This allows a more rapid treatment of the patient, with the advantagesindicated above.

Referring again to the side portions 3 c, with reference to FIG. 2, itcan be noted that, in the preferred embodiment illustrated, these do notdevelop exactly according to a perpendicular axis to that of the guidingelement 5 (more specifically, they do not lie on the plane on which theaxis of the guiding element 5 is normal): the side portions 3 c are infact slightly tilted (in a side view) towards the free end 5 a of theguiding element 5, specifically forming a petal.

The side portions 3 c therefore preferably develop, at least partly,along the generatrices of a cone (or truncated cone, depending on thecases) having as axis the longitudinal axis of the guiding element 5.

In this way, also due to the intrinsic elasticity of the elements 3 a(whether they be metal laminates or wires), when the ablation segment 3b is resting on the tissue to be ablated, they are able to dampen, bybending, small oscillations or physiological movements (of both thetissue and surgeon's hand), always keeping the ablation electrode 3 b incontact with the tissue itself, guaranteeing a reliable contact and aconsequent effective treatment, with the advantages discussed above.

For each petal 3 a, one of the side portions 3 c is preferably fixed tothe outer tubular body, whereas the other side portion extends (or isconnected) as far as the handpiece, where it is connected to themechanical activation elements or to the specific generator for this.

Each petal, in addition to being individually activated, can also beindividually extracted from the tubular body 4 a in which it is housedin a non-operating condition.

For this purpose, as can be seen in FIGS. 17, 18, 19, the side portion 3c of each petal is both mechanically and electrically connected to aspecific conductor 39.

In the preferred embodiment of FIGS. 17, 18, the conductor 39 isintegral with the petal 3 a, as it is produced with the same Nitinolwire, with the same diameter.

In this preferred embodiment, only one side portion 3 c of each petalextends as far as the handpiece, the other portion being fixed incorrespondence with the terminal end of the body 4 a, for example aterminal bush; the bush 37 therefore preferably slidingly houses a sideportion of each petal 3 c, whereas the other terminal portion of thesame petal is fixed to the bush 37 itself.

In the preferred example of FIGS. 11-21, there are four petals 3 a,therefore eight side portions 3 c and consequently there will be fourconductors 39 which extend as far as the handpiece.

It should be noted that in this preferred embodiment, the conductors 39of each petal substantially extend as far as the handpiece housed insidethe body 4 a, in the space between this and the body 4 b.

In this route that passes from the petals to the handpiece, theconductors 39 are spirally wound in said space between the bodies 4 aand 4 b.

Each conductor 39 is electrically isolated from the other so that thepowering of one of these does not cause the powering of those nearby.

Again, with brief reference to the ablation electrodes 3 b, in aparticularly advantageous embodiment, they can be selectively activated:in short, each segment 3 b and/or each element 3 a is connected to apower source separately from the others and can be activatedindividually; for this purpose, the ablation apparatus of the inventioncomprises a number of radiofrequency electric energy generators equal tothat of the petals, which are connected separated and individually toeach generator by means of the conductors 39.

Each electrode 3 b and/or each petal 3 a is therefore connectedindividually to and can be powered individually by an electric energysource (preferably a radiofrequency generator).

The surgeon can therefore choose which electrodes 3 b and/or petals 3 ato activate depending on the treatment conditions, and can also repeatit only in correspondence with areas that have not been sufficientlytreated and/or avoid activating areas of risk for the patient.

In a particularly advanced embodiment, each petal 3 a can beadvantageously moved individually (with respect to the others) betweenthe rest condition and the, extracted, operating condition.

This allows the surgeon to extract only the ablation petals 3 a that arenecessary, for example when the dimensions/forms of the tissue to beablated have physiological features that make it advisable.

The ablation petals 3 a are optionally rotatingly associated with thetelescopic body 4 so that they can be rotated without causing the body 4and/or the positioning head 2 to also rotate; this is obtained, forexample in the case of the embodiment of FIGS. 11-21, making theterminal bush 37 (provided with seats in which the conductors 39 passaxially before being connected to the portions 3 c) rotate freely withrespect to the body 4 a.

The petals 3 a are preferably controlled by the handpiece of the device,by means of a mechanical, or electric or pneumatic control.

This allows a high flexibility of use to be obtained together with aconsiderable precision: when the surgeon has positioned the catheter 1in an operating position, he keeps it in the correct position thanks tothe positioning head 2 (to which further reference will be madehereunder), and can proceed with treating the various parts of tissue,extracting, rotating and activating the petals 3 a alone, without havingto repeat the positioning phase each time.

This contributes, inter alia, to making the treatment even more rapid,with the advantages indicated above.

According to an optional and advantageous characteristic, alsoregardless of the other features of the invention, at leastone—preferably a plurality—of additional conductors 38 is envisaged,partly housed in the telescopic tubular body 4, shown in the preferredembodiment of FIGS. 11-21.

The additional conductors 38 are also housed in the body 4 a, in thespace between this and the body 4 b, adjacent to the conductors 39, inparticular spirally arranged and interspersed with the latter.

Said additional conductors 38 are not in electric contact with thepetals 3 a and serve to reduce the eddy currents and allow a bettercontrol of the energy supplied to each petal during the operating phaseof the catheter.

These advantages are more strongly felt when ablation petals such asthose described above are used, which are connected independently to thegenerators; in this way, eddy currents can be avoided, which could makethe treatment less precise.

This advantage is offered when the ablation apparatus comprisesdiscretized electrodes and also when the electrodes are continuous, asin the catheter described above.

Eddy currents are generated on the electrodes that are not fed due tothose that are being fed at the same time by the respective generatorand also cause the powering of the electrodes which, on the other hand,should not be fed.

The additional conductors 39 are preferably completely contained in thetelescopic tubular body 4 and exit from this only on the side of thehandpiece.

Each additional conductor is preferably “U”-folded inside the body, withthe two free ends exiting from the proximal side and the folded partwhich extends into the tubular body as far as its end; alternatively andpreferably, all or only part of the additional conductors can beelectrically connected to each other.

The additional conductors 39 are preferably copper wires.

When the supply conductors of the electrodes are spirally wound in thebody 4, the additional conductors 38 are interposed between them, sothat each supply conductor 39 of a petal is adjacent, on the twoopposite sides, to two branches of the same—or different—additionalconductors 38.

This arrangement, shown in detail in FIGS. 17, 18, 19 allows thephenomenon of eddy currents described above to be completely or almostcompletely eliminated, so that the ablation treatment can be controlledwith extreme accuracy.

Finally, according to another optional and advantageous feature, theablation head 3 comprises at least one contact sensor, capable ofmeasuring the contact with the surface to be treated, effecting thetreatment with greater precision.

In particular, in one embodiment, said contact sensor is a capacitivesensor, which indirectly measures the percentage of the electrode 3 bwhich is in contact with the tissue.

If the ablation is obtained by means of RadioFrequency (RF), forexample, the same electrode 3 b acts as electrode of the capacitivesensor: by passing a control current, it is in fact possible to revealwhether the same is or is not in contact with the tissue.

With respect now to the positioning head 2, this comprises a pluralityof extractable positioning arms 2 a.

Said arms 2 c pass from a rest position, in which they are housed in theinner tubular body 4 b, to an extracted, operating, position, in whichthey protrude radially from this.

Also in this case, analogously to the ablation head 3, the extractablepositioning arms 2 a remain withdrawn during the insertion phase of thecatheter into the vein, until this has reached the area to be treated,so as not to represent an obstacle during this phase, and they areextracted to maintain the position reached, buffered against the wallsof the vein/artery to be treated.

In particular, the extractable arms 2 a are preferably housed betweenthe inner tubular body 4 b and the rod-like guiding element 5.

The extractable arms 2 a form a kind of positioning cage, destined forabutting inside the vein, so as to keep the ablation head correctly inposition in correspondence with the ostium of the vein itself.

In the embodiment illustrated, there are advantageously eightextractable positioning arms 2 a, but, more generically, there could betwo, three, four or more.

Also in this case, the extractable positioning arms 2 a are controlled,in the extraction/re-insertion movement (from the rest position to theoperating position and vice versa) by means of a mechanical systemsituated in the handpiece of the device and which allows the controlledand adjustable exiting of the extractable elements 2 a.

In other embodiments, the positioning head is an inflatable body (notshown) which is expanded from the rest position to the operatingposition, like a balloon.

Also in this case, the inflatable body is preferably housed, under restconditions, inside the tubular body 4.

The advantages of using a positioning head 2 provided with arms 2 a,with respect to the inflatable body, are, first of all linked to thefact that the former solution does not block the passage of blood in thevein, as would be the case, on the contrary, with a balloon inflatedinternally (possibly causing clots or pulmonary hypertension phenomena).

The inflatable body, moreover, has the advantage of being able to befilled with radio-opaque fluid for a better and more precisevisualization.

According to a particularly advantageous characteristic, regardless ofits practical embodiment, the positioning head 2 comprises at least onesensor capable of revealing electric potentials in the tissue,consequently allowing the completeness of the ablation effected, to berevealed.

This sensor, can be produced in various ways, according to the case.

It can, for example, be an electrode applied to the arms 2 a or to theinflatable body.

Alternatively, when the positioning head 2 comprises metal arms 2 a,these, in practice, form the electrode for the detection, thanks towhich the electric potentials of the vein are revealed and the isolationof the vein is verified during and at the end of the treatment.

As far as the positioning head 2 described above, is concerned, it isinteresting to note how this comprises, in both the embodiment describedabove and also in its variants 2″, 2′″, 2°, 2{circumflex over ( )}, Zwhich will be briefly described hereunder, at least one extractablepositioning arm 2 a (and 2 a″, 2 a″′, 2 a°, 2 a*, 2 a{circumflex over( )} in the variants described hereunder) that can be moved between arest position, in which it adheres to the rod-like guiding element 5 andis housed in the body 4 of the catheter, and an enlarged operatingposition, in which it protrudes from the rod-like guiding element 5,broadening out in a radial direction.

The guiding rod-like element 5 slides in the inner tubular body 4 b; thepositioning head 2, 2″, 2′″, 2°, 2*, 2{circumflex over ( )}under restconditions, has such dimensions that it can be inserted in the innertubular body 4 b.

The catheter 1 can then be inserted into the vein so as to occupy aminimum space and there are no protrusions which could obstruct itspassage in the patient's body, subsequently, when the catheter 1 is inthe area to be treated, the rod-like element 5 is extracted from theinner tubular body 4 b and, when the catheter has reached a correctposition, in which it must be fixed, the positioning head 2, 2″, 2″′,2°, 2*, 2{circumflex over ( )}, is enlarged or, rather, its arms 2 a, 2a″, 2 a″′, 2 a°, 2 a*, 2 a{circumflex over ( )} are enlarged, which passfrom a rest position to an enlarged position and can be abutted againstthe surrounding tissues, so as to keep the catheter 1 in position.

The synergy of advantages deriving from the combined use of an ablationhead 3 and a positioning head 2, according to the invention, aretherefore evident.

With respect to the description of the alternative forms of thepositioning head, reference should be made to FIGS. 6 to 10.

In the figures, the catheter 1 is shown with the ablation head in a restcondition and, for the sake of clarity, only the positioning head isillustrated.

In this respect, it should be noted that, in order to avoid encumberingthe present description, no further mention is made hereunder of theelements and characteristics in common with the head 2 and arms 2 a,already presented above; it should also be noted that the same partsillustrated in the previous figures are indicated with the samereference numbers.

FIG. 6 shows a positioning head 2″ in an enlarged condition, whichcomprises only one arm 2 a″, in the form of a spiral which developsaround the rod-like element 5.

When in an extracted condition, the arm 2 a″ rests with its coils on thetissue, helping to keep the catheter 1 in position.

FIGS. 7, 8, 9 and 10 show, in an enlarged condition, the positioningheads 2′″, 2°, 2* and 2{circumflex over ( )}each comprising arms 2 a′″,2 a°, 2 a* and 2 a{circumflex over ( )}which extend according todifferent geometries around the rod-like element 5:

-   -   the arms 2 a″′, in an extended condition, each form a kind of        rectangle (in a side view) with rounded edges,    -   the arms 2 a°, in an extended condition, each form a kind of        semicircle (in a side view),    -   the arms 2 a*, in an extended condition, each form a kind of        isosceles triangle (in a side view),    -   the arms 2 a{circumflex over ( )}, in an extended condition,        each form a kind of semi-arrow (in a side view) with rounded        edges.

It should be noted, moreover, that each extractable arm 2 a, 2 a″, 2a′″, 2 a°, 2 a* and 2 a{circumflex over ( )} is arched (even if it doesnot develop according an actual arc of circumference except for the arms2 a°) and extends substantially between said inner tubular body (4 b)and said free end (5 a) of said rod-like element (5).

Even if two arms are shown in the examples of these variants, three,four or more arms can be envisaged, similar to the arms 2 a describedabove.

With reference to FIGS. 11-21, which show a preferred embodiment, itshould be noted that, analogously to the conductors 39 of the petals,each arm 2 a of the head 2 also extends into the body 4 b as far as thehandpiece by means of elongated spiral-shaped portions 29.

Each elongated portion is preferably integral with the respective arm 2a and is produced in the same material, preferably conductive such asNitinol or similar.

Inside the body 4 b, more specifically in the space between this and theguidewire 5, each elongated portion 29 is electrically isolated from theothers, so that possible electric signals can be revealed (ortransmitted) by the arms 2 a independently of each other.

In the enclosed preferred embodiment, moreover, additional secondconductors 28 are envisaged for the positioning head, with advantagessimilar to those described above for the first additional conductors 38(relating to the eddy currents).

These additional conductors 28 develop on a helix having the same pitchand the same diameter with respect to the elongated portions 29, and areinterspersed with the latter, so that each elongated portion 29 of anarm 2 a is adjacent, at the two opposite sides, to two branches of thesame—or different—additional conductor(s) 28.

In short, the effects relating to the reduction in the phenomena of eddycurrents are thus reduced or even cancelled.

The additional conductors 28 are preferably made of copper, preferablyshaped like U-folded wires inside the body 4 b (or, alternatively,preferably all or part of them are electrically connected to eachother), between this and the guidewire, analogously to the additionalconductors 38 described above.

In the ablation apparatus, the above-mentioned additional dissipativeconductors 28, 38 are preferably electrically connected to ground.

The objectives indicated above have therefore been achieved.

1. A catheter for the ablation of tissues comprising: a telescopictubular body in turn comprising an external tubular body and an internaltubular body concentric with each other, and a rod-like guiding elementat least partly housed in the internal tubular body with at least onefree end protruding from the internal tubular body in correspondencewith a distal end of the telescopic body; a positioning head and anablation head in correspondence with the distal end of the telescopicbody, the positioning head being situated in the proximity of the freeend of the rod-like guide, and the ablation head in the proximity of thepositioning head, in a remote position with respect to the free end; acontrol handpiece at a proximal end of the telescopic body coupled withthe guiding element, the ablation head, the positioning head and thetelescopic tubular body; wherein the ablation head comprises at leasttwo ablation elements or petals that can be moved from a rest positionin which they are housed in the external tubular body and an operatingposition in which they protrude from the external tubular body like apetal; each of the ablation elements or petals comprising: a continuousablation electrode which extends without interruption over acircumferential peripheral portion of each petal, substantially along anarc of circumference having a longitudinal axis of the rod-like guidingelement as its center; two side portions of the petal, each connected toan end of the ablation electrode, in correspondence with a curvedsection, characterized in that the side portions and the ablationelectrode are integral with each other, formed by means of the samefolded metallic conductor, each ablation petal being separate anddistinct from another ablation petal of the ablation head, all theablation petals of the ablation head being separately connected to adistinct electric energy generator to cause a radiofrequency ablationand/or a pulsed field ablation in a powered ablation electrode conditionand wherein each ablation petal is produced with a single shape-memorymetallic conductor wire having a circular section with a diameter D,and, as L is the linear length of the ablation electrode, there is thefollowing ratio D/L ranging from 0.015 to 0.025.
 2. The catheteraccording to claim 1, wherein said ratio D/L is equal to about 0.02. 3.The catheter according to claim 1, wherein the two side portions of eachpetal are coated with an electrically insulating material, preferably aninsulating paint.
 4. The catheter according to claim 1 comprising, foreach petal, at least one conductor which extends as far as the handpiecefor individually powering each petal, wherein said conductor extendsinside the external body, in the space between this and the internalbody, preferably arranged spirally.
 5. The catheter according to claim 1comprising, for each petal, at least a first additional conductor atleast partly housed in the telescopic tubular body, and destined forpreferably extending from the handpiece to the end of the external body.6. The catheter according to claim 1, wherein each first additionalconductor develops spirally inside the external body, and wherein saidconductors alternate with at least one additional conductor, inside saidexternal body
 7. The catheter according to claim 1, wherein each petalcan be moved individually with respect to the others between the restcondition and the extracted, operating condition.
 8. The catheteraccording to claim 1, wherein the ablation petals are rotatinglyassociated with the telescopic body so that they can be rotated withoutcausing the body and/or the positioning head to also rotate.
 9. Thecatheter according to claim 1, wherein the positioning head comprises atleast one extractable positioning arm, said extractable positioning armbeing movable between a rest position, in which it is housed in theinternal tubular body, and an extracted, operating position, in which itprotrudes radially from the internal tubular body.
 10. The catheteraccording to claim 1, wherein the positioning head comprises at leastone sensor capable of revealing electric potentials in the tissue andallowing the completeness of the ablation effected, to be revealed. 11.The catheter according to the previous claim 9, wherein said at leastone positioning arm is metallic and forms the detection electrode. 12.The catheter according to claim 11, wherein each of said at least onepositioning arm is connected to at least one elongated portion whichextends as far as the handpiece, housed in the internal body andpreferably spiral-shaped.
 13. The catheter according to claim 12,wherein second additional conductors are envisaged for the positioninghead, which preferably develop spirally and are interspersed with saidelongated portions.
 14. An apparatus for the ablation of tissuescomprising a catheter according to claim 1 and at least one electricenergy generator for each petal of said catheter, electrically connectedto said petal.